Lawsuit filed in University of Oklahoma cancer vaccine case

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Lawsuit Filed in U. of Oklahoma Cancer Vaccine Case

Researcher Accused of Violating Scientific, Ethical Rules

By Jeff Levine

WebMD Washington Bureau Chief

Reviewed by Gary D. Vogin, MD

Jan. 30, 2001 (Washington) -- A vaccine study for a deadly type of skin cancer is now the subject of a lawsuit aimed at researchers at the University of Oklahoma at Tulsa and the Immunex Corporation, which co-sponsored the study.

Fourteen patients and their family members filed the complaint earlier this week, alleging they had suffered a variety of injuries, including battery. The lawsuit also charges that lead investigator J. Michael McGee, MD, flagrantly violated ethical and scientific standards during the 3-year vaccine trial.

Specifically, the plaintiffs claim that the researchers failed to meet the minimum requirements specified by the Nuremberg Code, adopted after the Nazi atrocities of World War II to protect patients' basic rights. "The voluntary consent of the human subject is absolutely essential," according to the code, which mandates that people must not be used as a means to an end.

That guideline was violated, says Alan Milstein, who represents those suing the university.

"These subjects were vulnerable because they had [melanoma], [and] are desperate for any cure," Milstein tells WebMD. "[They] have the ... right to be treated with dignity -- they have the right not to be guinea pigs."

Milstein successfully negotiated a settlement in the sensational Jesse Gelsinger case. The 18-year-old died in 1999, the first patient to do so directly as a result of experimental gene therapy. Following that incident, the federal government imposed tough, new oversight and safety standards on clinical trials.

However, the Gelsinger situation was different, Milstein says, because the young man was basically healthy, and these patients were at greater risk. "[They] are vulnerable to being seduced into participating into trials that [violate] regulations," he says.

The injectable vaccine -- which consisted of processed cancer cells -- resulted in a variety of painful symptoms ranging from boils to mood changes, according to the 130-page complaint. Overall, some 90 people got the shots and about 40 died, but it's not clear if the vaccine was to blame. Milstein hopes to show a connection, however, if the case isn't settled before it goes to court.

Former nurse coordinator Cherlynn Mathias worked on the OU-Tulsa study for about a year, but tells WebMD she "realized the trial was off track" from the beginning. Finally, after observing many irregularities, she blew the whistle, causing a big shake-up in the university's research program.

The suit claims the vaccine failed to meet good manufacturing standards and was prepared from "potentially infected cell lines." One pregnant plaintiff was inoculated with the vaccine even though she was pregnant, an apparent violation of study protocol. The patient later gave birth to a child with immune problems, according to Milstein.

Following an investigation, the U.S. Office of Human Research Protections shut down federally funded experiments at the university's Health Science Center in Tulsa. According to Gary Raskob, PhD, associate vice president for clinical research at the university, that suspension has been lifted following a commitment by the school to overhaul its education and training program for researchers.

Meanwhile, the FDA is allowing about 10 melanoma patients to re-enroll in the controversial vaccine trial, but McGee is out of the picture, according to Raskob.

"Because our primary concern is the safety of our patients -- and the trust that people have in the university to conduct these [studies] in a proper way -- we're committed to doing everything we can to fully comply with all federal regulations -- and, in fact, to go well above the minimum requirements so that we can become a model," Raskob tells WebMD.

Even so, he can't comment on the lawsuit.

The Immunex Corporation, the lawsuit contends, "knew or should have known" that McGee failed to meet the study requirements. Furthermore, McGee wrongly portrayed the vaccine as a "cure," says the suit, even though it was in the early stages of development. Both Immunex and McGee were unavailable for comment. Termination proceedings against McGee have been under way since last year.

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